A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide
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ClinicalTrials.gov Identifier: NCT00234520 |
Recruitment Status
:
Completed
First Posted
: October 7, 2005
Last Update Posted
: June 27, 2008
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Condition or disease |
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Acromegaly |
Study Type : | Observational |
Enrollment : | 200 participants |
Time Perspective: | Prospective |
Official Title: | A Multicentre Prospective Controlled Observer Blinded Cohort Study in Patients With Acromegaly to Evaluate the Risk of Cardiac Valvular Regurgitation in Patients Treated With Lanreotide Relative to Patients Treated With Octreotide |
Study Start Date : | May 2003 |
- Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months
- Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 6 months
- Risk in each of the 4 valves at 6 & 12 months
- Risk of significant regurgitation in each valve at 6 & 12 months
- Prevalence of valvular regurgitation at baseline
- Assessment of GH and IGF-1 levels at baseline, 6 months & 12 months

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient has a diagnosis of Acromegaly
- Patient is being treated with lanreotide or octreotide in any dose form at the selection visit or is a de novo patient who is due to commence treatment within 2 weeks of baseline
- Patient started treatment with either lanreotide or octreotide when both products were available on the market in their country
- Patient must not change treatment form lanreotide to octreotide or vice versa for the duration of the study
Exclusion Criteria:
- Patients with known significant valve abnormalities prior to treatment with either lanreotide or octreotide
- Patients who have received treatment with a somatostatin analogue other than lanreotide or octreotide for more than 3 months
- Patients who have received treatment with a GH antagonist for more than 3 months
- Patients who have had heart valve replacement therapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234520

Study Director: | France Catus, MD | Ipsen |
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00234520 History of Changes |
Other Study ID Numbers: |
2-47-52030-721 |
First Posted: | October 7, 2005 Key Record Dates |
Last Update Posted: | June 27, 2008 |
Last Verified: | June 2008 |
Additional relevant MeSH terms:
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Endocrine System Diseases Octreotide Lanreotide Angiopeptin Gastrointestinal Agents Antineoplastic Agents, Hormonal Antineoplastic Agents |